Codexis, Inc. recently announced that Nestlé Health Science has exercised its option to obtain an exclusive license for the global development and commercialization of Codexis’ novel, orally delivered enzyme CDX-6114 for the management of phenylketonuria (PKU), an orphan metabolic disorder. Nestlé Health Science was granted this option under the Development, Option, and Licensing Agreement with Codexis announced in October 2017. CDX-6114 is Codexis’ first internally developed biotherapeutic product candidate.

The exercise of the option triggers a $3-million milestone payment. Upon exercising its option, Nestlé Health Science has now assumed all responsibility for future clinical development and commercialization of CDX-6114.

“We are proud to have discovered an enzyme that shows promise as a novel treatment for patients with PKU and are delighted that Nestlé Health Science has elected to take on its continued development,” said Codexis President and CEO John Nicols. “The exercise of this option further validates our strategy to partner biotherapeutics discovered using our CodeEvolver protein engineering platform, and to do so early in the process of clinical development.”

“We are excited about taking the next step in developing this enzyme that could lead to the first orally available and convenient therapeutic option for those afflicted with PKU,” said Greg Behar, CEO, Nestlé Health Science. “PKU is the result of a missing enzyme, and left untreated it can lead to intellectual disability, seizures and cognitive and behavioral disabilities. Current treatment options are limited, with most patients managing PKU through restrictive diets. CDX-6114 is a therapeutic enzyme candidate that compensates for the missing natural enzyme with the advantage of being orally dosed and stable in the gastrointestinal tract which presents an attractive option for the management of the disease.”

PKU is an inborn metabolic disorder resulting from a mutation in the gene for the enzyme that converts the essential amino acid phenylalanine, which is present in almost all dietary protein, into tyrosine. As a result of this deficiency, phenylalanine builds up to levels that are toxic in the brain, causing serious neurological symptoms including intellectual disability, seizures and cognitive and behavioral disabilities. To avoid phenylalanine toxicity and the most severe disease symptoms, individuals with PKU must follow a strict, lifelong diet that is low in phenylalanine and must supplement their diet with a synthetic phenylalanine-free formula to provide sufficient nutrients. Maintaining a strict, lifelong diet is a challenge for individuals with PKU. There are an estimated 50,000 people with PKU in the developed world.

Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognized leader in the field of nutritional science. NHSc is committed to empowering healthier lives through nutrition for consumers, patients, and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and VMS brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world, who are committed to making a difference in people’s lives, for a healthier today and tomorrow. For more information, visit www.nestlehealthscience.com.

Codexis is a leading protein engineering company that applies its proprietary CodeEvolver technology to develop proteins for a variety of applications, including as biocatalysts for the commercial manufacture of pharmaceuticals, fine chemicals and industrial enzymes, and enzymes as biotherapeutics and for use in molecular diagnostics. Codexis’ proven technology enables improvements in protein performance, meeting customer needs for rapid, cost-effective and sustainable manufacturing in multiple commercial-scale implementations of biocatalytic processes. For more information, visit www.codexis.com.